Hydroxyurea
These highlights do not include all the information needed to use HYDROXYUREA Capsules safely and effectively. See full prescribing information for HYDROXYUREA Capsules. HYDROXYUREA capsules, USP, for oral useInitial U.S. Approval: 1967 ---------------------RECENT MAJOR CHANGES--------------Warnings and Precautions, Pulmonary Toxicity (5.9) 7/2019
Approved
Approval ID
e76fd60e-7644-48c5-9857-3608a045000b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyurea
PRODUCT DETAILS
NDC Product Code0904-6939
Application NumberANDA075340
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 10, 2019
Generic NameHydroxyurea
INGREDIENTS (8)
HYDROXYUREAActive
Quantity: 500 mg in 1 1
Code: X6Q56QN5QC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT